Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
Study Overview
Brief Summary
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Periodontitis stage III-IV
- •Full-mouth plaque score (FMPS) < 25% at the 1-month re-evaluation
- •Full-mouth bleeding score (FMBS) < 25% at the 1-month re-evaluation
- •Signed informed consent
Exclusion Criteria
- •Age < 18 yo
- •Pregnancy or lactation
- •Heavy smokers (>10 die)
- •Conditions or diseases influencing periodontal healing
- •Patients that cannot complete the 6 months follow-up
Outcomes
Primary Outcomes
Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
Time Frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT
Secondary Outcomes
- Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Monetary cost for the treatment plan in €([Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.])